FDA warns JBS after discovering pentobarbital in tallow

The US Food and Drug Administration (FDA) on April 23 issued a warning letter to JBS Souderton, Inc. after discovering pentobarbital in tallow products manufactured at its rendering facility in Pennsylvania, which were used in the production of pet foods. Pentobarbital is a drug used to euthanize dogs and cats in the US.

This comes after the FDA issued formal notification of pentobarbital contamination from a customer in February 2018, and another from the Pennsylvania Department of Agriculture (PDA) in April 2018. The warning letter states JBS continued to distribute contaminated product after receiving the two notifications.

Inspections were conducted throughout 2018 as a joint effort with the PDA. The warning letter concluded that JBS had violated Current Good Manufacturing Practice (CGMP) requirements for animal food, resulting in adulterated products, aside from the presence of pentobarbital in tallow products.

The FDA stated JBS had “failed to examine raw materials and other ingredients to ensure that they are suitable for manufacturing and processing into animal food,” specifically those containing pentobarbital.

Trace levels of pentobarbital were detected in a sample taken August 2018, after JBS reported in May 2018 that the facility had taken several precautionary measures to prevent this by vetting the food safety practices of its suppliers, refusing certain ingredients, and cleaning equipment thoroughly, according to the FDA.

“This indicates that the changes you have made to your examination of raw materials and other ingredients from your suppliers may not be sufficient to prevent pentobarbital contaminated ingredients, such as those potentially sourced from euthanized animals, from entering your facility and contaminating your finished tallow product,” wrote Evelyn Bonnin, program division director and district director for the FDA’s Human & Animal Food Division II East in Baltimore, Maryland.

The FDA took nine samples from the facility in March 2018, of which four tested positive for pentobarbital, and six sub-samples in August 2018, of which one contained trace levels of the drug. The PDA also collected several products at the JBS facility and at its customer’s facilities that indicated levels of pentobarbital.

“This presence of pentobarbital causes your animal food to be adulterated because the food contains a new animal drug that is unsafe because it was not used in conformance with the drug approval, which does not have a tolerance for pentobarbital residue in the edible tissue of animals,” Bonnin stated.

JBS was given 15 days to notify the FDA of its plans to implement specific corrective actions or dispute the warning.